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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Newly Enrolled


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General
522 Number / Requirement Number PS130041 / PSS001
Current Plan Approved 05/27/2016
Study Name Newly Enrolled
Root Document Number K121858 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a post-market, prospective, multi-center, longitudinal, comparative study to compare the rates

of acute and near-term serious complications in the global fibroid ablation (GFA) subjects (groups combined) to the acute and near-term treatment-related serious adverse event rates of the pivotal (pre-market) study. The 522 order questions are being addressed as endpoints in a larger study being conducted by the sponsor (the Treatment Results of Uterine Sparing Technologies Study, or “TRUST”).

Study Population Description

Premenopausal female patients = 18 years old who have symptomatic fibroids, who desire uterine

conservation, and who are indicated for a surgical intervention for their symptoms.



Inclusion Criteria: Women who:

1. Are = 18 years old and menstruating

2. Have symptomatic uterine fibroids

3. Have a uterine size =16 gestational weeks as determined by pelvic exam

4. Have all fibroids that are less than 10 cm in any diameter

5. Desire uterine conservation

6. Have had a normal Pap smear within the past 36 months defined as “no untreated cervical malignancy or dysplasia.”

7. Are willing and able to comply with all study tests, procedures, and assessment tools

8. Are capable of providing informed consent.

Exclusion Criteria:

Women who:

1. Have contraindications for laparoscopic surgery and/or general anesthesia.

2. Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)

3. Patients requiring major elective concomitant procedures (e.g., hernia repair)

4. Are pregnant or lactating

5. Have taken any depot GnRh agonist within three months prior to the screening procedures

6. Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment

7. Have chronic pelvic pain known to not be due to uterine fibroids

8. Have known or suspected endometriosis Stage 3 or 4, or adenomyosis

9. Have active or history of pelvic inflammatory disease

10. Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years

11. Have had pelvic radiation

12. Have a non-uterine pelvic mass over 3 cm

13. Have a cervical myoma

14. Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1

submucous fibroids that are better treated via hysteroscopic methods

15. In the medical judgment of the investigator should not participate in the study

16. Are not willing to be randomized to treatment.

Sample Size 100 subjects will be enrolled at up to 6 clinical sites within the United States.
Data Collection The 522 order questions are being addressed as endpoints in a larger study being conducted by the sponsor (the Treatment Results of Uterine Sparing Technologies Study, or “TRUST”).



Primary Endpoints:

• Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near- term treatment-related SAE rates in the pivotal study.



Secondary Endpoints:

• Incidence of serious complications per investigator-surgeon during training and post training.

• Investigator/surgeon feedback using the Acessa™ Procedure Evaluation Form.

Follow-up Visits and Length of Follow-up Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure, and office or phone follow-up visits at 4-8 weeks post treatment. Telephone follow up will occur at 24 to 72 hours post treatment.



Newly Enrolled Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/29/2014 08/21/2014 On Time
1 yr report 02/28/2015 02/27/2015 On Time
18 month report 08/29/2015 08/31/2015 Overdue/Received
2 yr report 02/28/2016 02/26/2016 On Time
3 yr report 02/27/2017    
4 yr report 02/27/2018    
5 yr report 02/27/2019    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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